POLYMORPH OF SODIUM NERIDRONATE AND PREPARATION PROCESS THEREOF

Canada Patent

PATENT NO 3126088
APP PUB NO CA-3126088-A1
SERIAL NO

3126088

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The present invention relates to a process for the preparation of crystalline polymorphic form B of sodium neridronate, comprising: a) reacting 6-aminohexanoic acid with a mixture of phosphorous acid and methanesulfonic acid; b) adding phosphorus trichloride; c) diluting the mixture obtained in the previous step (b) with water, and heating said mixture diluted with water; d) cooling the heated mixture, and slowly adding sodium hydroxide to a pH in the range from 3 to 5, obtaining a suspension; e) cooling the suspension obtained in step (d), then slowly adding ethanol to obtain the precipitation of the crystalline sodium neridronate; f) recovering the crystalline polymorphic form B of sodium neridronate formed in the step (e). The crystalline form B of sodium neridronate may be employed in the preparation of pharmaceutical forms for use in the treatment of musculoskeletal and calcium metabolism disorders.

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